BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23304008 · Received October 15, 2025

    Report

    Report Number
    1000113657-2025-00371
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 20, 2025
    Manufacturer
    SINOCARE INC
    Product Code
    NBW
    UDI-DI
    00021292015084
    PMA / PMN Number
    K231476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF: 20-NOV-2025 H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS H10: METER, TEST STRIPS AND 1 BOTTLE OF CONTROL SOLUTION WERE RETURNED FOR EVALUATION (TRIVIDIA HEALTH, INC.). DEFECT FOUND ON RETURNED STRIPS: HIGH READINGS. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER OR CONTROL SOLUTION. R&D TESTED THE RETURNED AND RETENTION STRIPS WITH LEVEL- 1 AND 2 CONTROL SOLUTION USING THE CUSTOMER¿S METER. THE RETURNED STRIPS PRODUCED HIGH READINGS, WHILE THE RETENTION SAMPLE RESULTS REMAINED WITHIN THE ASSIGNED RANGE. SINOCARE RETENTION STRIP LOT TESTED WITHIN SPECIFICATION ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER, TEST STRIPS AND CONTROL SOLUTION WERE RETURNED - PRODUCT EVALUATION IN-PROCESS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTES: 1. IN MULTIPLE FIELDS THE FORM INDICATES THAT MANUFACTURER RECEIVED PRODUCT, HOWEVER TRIVIDIA HEALTH, INC. (USA) RECEIVED THE PRODUCTS RETURNED AND WILL BE CONDUCTING THE PRODUCT EVALUATION ON THE COMING DAYS. 2. SINOCARE (A FOREIGN MANUFACTURER, FEI # (B)(4)) AND TRIVIDIA HEALTH, INC. (A U.S. COMPANY/IMPORTER, FEI # (B)(4) HAVE ENTERED INTO A CUSTOMER SERVICE AGREEMENT. TRIVIDIA HEALTH, INC. HANDLES CUSTOMER COMPLAINTS FOR THE TRUENESS¿ BLOOD GLUCOSE MONITORING SYSTEM AND TRUENESS¿ AIR BLOOD GLUCOSE MONITORING SYSTEM (K231476 - CLASS 2) AND RECORDS CUSTOMER INFORMATION, ESTABLISHING A UNIQUE COMPLAINT NUMBER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 122, 123, 107, 126 AND 93 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/03/2026 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 122 MG/DL DATE: (B)(6) 2025 TIME: 9:14AM FASTING AM. RESULT 2: 123 MG/DL DATE: (B)(6) 2025 TIME: 4:52PM FASTING AM . RESULT 3: 107 MG/DL DATE: (B)(6) 2025 TIME: 9:22AM FASTING AM . RESULT 4: 126 MG/DL DATE: (B)(6) 2025 TIME: 8:26AM FASTING AM. RESULT 5: 93 MG/DL DATE: (B)(6) 2025 TIME: 8:07AM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289291 TRUENESS SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP, TNS 50CT 4R8219 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown